Trials / Completed
CompletedNCT01406327
Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 900 (estimated)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The objective of this post-marketing surveillance study is to evaluate the incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan basd on prescribing information under the conditions of general clinical practice and also to grasp the following items; 1. Unknown adverse drug reactions (ADRs) 2. Incidence of ADRs to medical products in actual clinical practice 3. Factors influencing safety of ambrisentan 4. Factors influencing efficacy of ambrisentan 5. Prognosis of subjects as well as efficacy and safety of ambrisentan in long-term use (VOLIBRIS® is a trademark of Gilead Sciences, Inc,. that GSK uses under license.)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ambrisentan | Ambrisentan |
Timeline
- Start date
- 2010-12-14
- Primary completion
- 2020-02-28
- Completion
- 2020-02-28
- First posted
- 2011-08-01
- Last updated
- 2020-09-03
Source: ClinicalTrials.gov record NCT01406327. Inclusion in this directory is not an endorsement.